Method for carrying out ultrasonic correction of body shape without surgical intervention

FIELD OF THE INVENTION

The present invention is related to lipolysis in general and, in particular, ultrasonic lipolysis.

Links to applications filed

The applicants of the present application claims priority based on US application №09 / 752,530, of January 3, 2001 entitled "Method and apparatus for correcting the shape of the body without surgery by digestion of adipose tissue" and US application №N / A on 29 October 2001, entitled " Ultrasonic correction of the body without surgery. "

BACKGROUND

The following US patents are prior art: 4,986,275; 5,143,063; 5,143,073; 5,209,221; 5,301,660; 5,431,621; 5,507,790; 5,526,815; 5,884,631; 6,039,048; 6,071,239; 6,113,558; 6,206,873.

SUMMARY OF THE INVENTION

The present invention provides an improved apparatus and method of ultrasonic lipolysis.

Thus, in accordance with a preferred embodiment of the present invention provides a method for adipose tissue digestion, comprising the following steps:

direction of the focused ultrasonic radiation to the target area to the area of ​​the body containing adipose tissue; and

modulation of the focused ultrasonic radiation so as to selectively cleave the fatty tissue in the target area, and generally not cleave nonfat tissue in the target area.

Additionally in accordance with a preferred embodiment of the present invention provides a method for adipose tissue digestion, comprising the following steps:

generating, by a source outside a body, ultrasonic radiation, which selectively cleaves the adipose tissue and generally does not cleave nonfat tissue; and

direction of ultrasound radiation from a source outside the body to the target area of ​​the body containing the adipose tissue.

Further, in accordance with a preferred embodiment of the present invention provides a method for adipose tissue digestion, comprising the following steps:

defining areas of the body, at least in part, by determining the spatial characteristics of the body; and

direction of ultrasonic radiation into a plurality of target areas within the zone target areas that contain fat tissue, to selectively break down fat tissue in the target areas and, in general, do not cleave nonfat tissue in the targeted areas.

Additionally in accordance with a preferred embodiment of the present invention provides a method for adipose tissue digestion, comprising the following steps:

direction of ultrasonic radiation into a plurality of target areas within the zone target areas that contain fat tissue, to selectively break down fat tissue in the target areas and, in general, do not cleave nonfat tissue in the targeted areas; and

computer monitoring a plurality of target areas, despite the movement of the body.

Also further in accordance with a preferred embodiment of the present invention, an apparatus for the splitting of adipose tissue, comprising:

directing the focused ultrasonic radiation device, directing focused ultrasonic radiation to the target area within the zone of the body containing adipose tissue; and

modulator, operating in conjunction with the guiding device of ultrasonic radiation, in order to create a focused ultrasound radiation to selectively break down fat tissue in the target area, and is generally not cleave nonfat tissue in the target area.

Further in accordance with a preferred embodiment of the present invention, an apparatus for the splitting of adipose tissue, comprising:

source located outside the body, generating ultrasonic radiation;

directing ultrasonic radiation device using ultrasonic waves for the selective cleavage of adipose tissue in the target area, without splitting, in general, non-fatty tissues in the target area of ​​the body containing the adipose tissue.

Further, in accordance with a preferred embodiment of the present invention, an apparatus for the splitting of adipose tissue, comprising:

determinant area defining area of ​​the body, at least in part, by determining the spatial characteristics of the body; and

guide means directing the ultrasonic waves into a plurality of target areas within the zone, the target areas which contain adipose tissue, to selectively cleave the fatty tissue in focal areas without splitting with nonfat tissue in the targeted areas.

Further, in accordance with a preferred embodiment of the present invention, an apparatus for the splitting of adipose tissue, comprising:

guide means directing the ultrasonic waves into a plurality of target areas within the zone, the target areas which contain adipose tissue, to selectively cleave the fatty tissue in focal areas without splitting with nonfat tissue in focal areas; and

module computer monitor, computer monitor providing a plurality of target areas, despite the movement of the body.

The direction of the focused ultrasound radiation generally prevents cleavage of tissue outside the target region.

In accordance with a preferred embodiment of the present invention, the method also includes ultrasonic imaging zone, at least partially, simultaneously with the direction of radiation of the focused ultrasound to the target area.

Operation of the ultrasonic emission direction includes positioning at least one ultrasonic transducer relative to the body in order to direct the focused ultrasonic waves to the target area.

The operation direction can also include a change in focus of at least one ultrasonic transducer in order to direct the focused ultrasonic waves to the target area. Changing the focus may change the volume of the target area and / or distance to the target area by at least one ultrasonic transducer.

The operation direction can also include the location of at least one ultrasonic transducer relative to the body in order to direct the focused ultrasonic waves to the target area.

The method also includes monitoring the ultrasonic radiation on the outer surface of the body adjacent the target area.

Additionally, the method includes monitoring the formation of voids in the target area.

Direction is produced from the ultrasonic transducer disposed outside the body.

In accordance with a preferred embodiment of the present invention, the ultrasound radiation has a frequency in the range of 50-1000 kHz, more preferably in the range of 100-500 KHz, and most preferably in the range of 150-300 KHz.

Preferably, the modulation provides a duty cycle ratio of 1: 2 to 1: 250, more preferably - 1: 5 to 1:30, and most preferably from 1:10 to 1:20.

In accordance with a preferred embodiment of the present invention, the modulation provides between 2 and 1000 sequential cycles at amplitude above the threshold for the formation of voids, more preferably from 25 to 500 sequential cycles at amplitude above the threshold for the formation of voids, and most preferably from 100 to 300 consecutive cycles, amplitude exceeding the threshold of the formation of voids.

Preferably, the modulation is performed in the form of amplitude modulation of the ultrasonic radiation time.

Operation direction includes directing focused ultrasound radiation into a plurality of target areas in the time sequence.

In accordance with a preferred embodiment of the present invention, an operation direction includes directing focused ultrasonic radiation in several areas of a plurality of target areas for periods of time which at least partially overlap.

Preferably, at least some of the plurality of focus areas at least partially overlap in space.

In accordance with a preferred embodiment of the present invention, the method comprises determining the area of ​​the body by marking at least one portion of the body surface. The method may also include determining zone by selecting at least one depth in the body and / or by detecting adipose tissue in the body and / or by identifying uncleaved adipose tissue.

Preferably, the operation also includes determining the direction of the target areas as the nodes uncleaved adipose tissue within the zone.

In accordance with a preferred embodiment of the present invention, modulation of ultrasonic radiation for selective cleavage of adipose tissue in a plurality of target areas operate in a time sequence, wherein the selective cleavage of adipose tissue in each target area is performed only after the detection of undigested fat tissue in the art.

Preferably, the method also includes computer tracking target area, despite the movement of the body.

Preferably, computer tracking comprises detecting changes in the position of markings on the body and using the detected changes to track the location of target areas in the body.

Preferably, the modulation is performed in a modulation amplitude decreasing with time, with an amplitude exceeding the threshold of formation of voids.

In one embodiment, a method of splitting the adipose tissue is characterized in that the direction of radiation of the focus comprises changing at least one ultrasonic transducer for directing focused ultrasonic radiation to the target area.

In one embodiment, a method of splitting the adipose tissue is characterized in that the focus change results in a change of volume of the target area.

In one embodiment, a method of splitting the adipose tissue is characterized in that the focus change results in a change of the distance between the target region and at least one, the ultrasonic transducer.

In one embodiment, a method of splitting the adipose tissue further comprises an ultrasonic tracking radiation on the outer surface of the body adjacent the target area.

In one embodiment, a method of splitting the adipose tissue is characterized in that the direction of radiation of the focus comprises changing at least one ultrasonic transducer in order to direct the focused ultrasonic waves to the target area.

In one embodiment, a method of splitting the adipose tissue is characterized in that the focus change results in a change of volume of said target area.

In one embodiment, a method of splitting the adipose tissue is characterized in that the focus change results in a change of the distance between the target region and at least one, the ultrasonic transducer.

In one embodiment, a method of splitting the adipose tissue further comprises an ultrasonic tracking radiation on the outer surface of the body adjacent the target area.

In one embodiment, the device for cleavage adipose tissue characterized in that said guiding device is arranged to adjust the focus of at least one ultrasonic transducer for directing focused ultrasonic radiation to the target area.

In one embodiment, a device for splitting the fat tissue is characterized in that the focus change leads to a change in volume of said target area.

In one embodiment, a device for splitting the fat tissue is characterized in that the focus change results in a change of distance between said target region and said at least one, the ultrasonic transducer.

In one embodiment, a device for splitting the fat tissue is characterized in that it further comprises a sensor, which monitors the formation of voids in the target area.

In one embodiment, a device for splitting the fat tissue is characterized in that the guide is arranged to change the focus of at least one ultrasonic transducer for directing ultrasonic radiation to the target area.

In one embodiment, a device for splitting the fat tissue is characterized in that the focus change results in a change of volume of the target area.

In one embodiment, a device for splitting the fat tissue is characterized in that the focus change results in a change of the distance between the target region and at least one, the ultrasonic transducer.

In one embodiment, a device for splitting the fat tissue is characterized in that it comprises a sensor which monitors ultrasonic waves on the outer surface of the body adjacent the target area.

In one embodiment, a device for splitting the fat tissue is characterized in that it is arranged to generate ultrasonic waves with frequencies in the range of 50 KHz-1000 KHz.

BRIEF DESCRIPTION OF THE DRAWINGS Apps

The present invention may be more fully appreciated when considering the detailed description together with the accompanying drawings and appendix, wherein:

1 illustrates in simplified form the overall structure and operation of ultrasonic lipolysis apparatus constructed and operative in accordance with a preferred embodiment of the present invention;

Figure 2 is a simplified block diagram of a preferred power source and modulator showing the variation of ultrasonic pressure over time in accordance with a preferred embodiment of the present invention;

3A and 3B illustrates in simplified form the appearance of an operator interface display during normal operation and deviations from the normal operation, respectively;

Figure 4 is a simplified block diagram of an ultrasonic lipolysis apparatus constructed and operative in accordance with a preferred embodiment of the present invention; and

5A, 5B and 5C are together a simplified flowchart illustrating operator steps in carrying out lipolysis procedure in accordance with a preferred embodiment of the present invention.

Brief description of the application

The application contains computer printouts, which together represent a computer tracking module in accordance with a preferred embodiment of the software of the present invention.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENT

1 shows a simplified diagram of the overall structure and operation of ultrasonic lipolysis apparatus constructed in accordance with a preferred embodiment of the present invention. As shown in Figure 1, the generator and the guiding means of ultrasonic radiation, for example, the transducer 10 is located outside the body, it generates ultrasonic waves which, by proper arrangement of the transducer 10 relative to the body, is directed to the target area within the body 12 and acts so that allows to selectively cleave the fatty tissue in the target area and generally do not cleave nonfat tissue in the target area.

In a preferred embodiment, the generator and directing ultrasonic radiation device used in the present invention comprise a ultrasonic therapeutic transducer 13 having a curved phased array 14 of piezoelectric elements 15, usually in the shape of a sphere or a cylinder portion and having a conductive coating 16 on its opposite surfaces. Piezoelectric elements 15 may be formed of any suitable configuration, shape, and may be distributed in any suitable manner. The intermediate member 18 made of a material such as polyurethane, having an acoustic impedance the same as that of soft mammalian tissue, generally fills the concave cavity formed by the phased array 14 and constitutes a contact surface 20 for contact with the body, typically via a suitable coupling gel (not shown). Contact surface 20 may be flat, but not necessarily.

Suitably modulated AC current is supplied through the conductors 22 to conductive coatings 16 to the piezoelectric elements 15 create the desired output flow of the focused acoustic radiation.

In accordance with a preferred embodiment of the present invention, the image forming part 23 of ultrasonic transducer embedded in the transducer 10 and typically comprises a piezoelectric element 24 having conductive surfaces 26 associated with opposite surfaces of said element 24. Suitably modulated AC current is supplied through the conductors 32 to conductive surfaces 26 to the piezoelectric element 24 creates the necessary output stream of acoustic radiation. Conductors 32, coupled to surfaces 26, also provide a transmission output stream information relating to an image from the imaging unit 23 of the ultrasonic transducer.

It should be noted that it may be any commercially available ultrasonic transducer or, in an alternative embodiment, the image forming part 23 of ultrasonic transducer can be eliminated from the construction.

It should also be noted that there may be used various types of ultrasonic transducers 10. For example, such transducers may include multiple piezoelectric elements, multilayered piezoelectric elements and piezoelectric elements of various shapes and sizes, installed in a phased array.

In a preferred embodiment of the present invention shown in Figure 1, a generator and an ultrasonic radiation guide device integrated in the converter 10. In an alternative embodiment, the function generating and focusing this radiation can be performed by separate devices.

In accordance with a preferred embodiment of the present invention, a skin temperature sensor 34, such as an infrared sensor may be installed near the image forming unit 23 of the ultrasonic transducer. Further, in accordance with a preferred embodiment of the present invention, next to the image forming unit 23, the ultrasonic transducer may also be mounted converter temperature sensor 36 such as a thermocouple.

The ultrasonic transducer 10 receives suitably modulated alternating current from the power supply unit 40 and a modulator forming part of control subsystem 42. Control subsystem 42 also typically includes a computer 44 controls lipolysis connected also with the chamber 46, such as a video camera, and a display 48. The source node 40 Power modulator and configured according to the preferred embodiment is shown in Figure 2 and described below. The ultrasonic transducer 10 is positioned automatically or semi-automatically by means of the positioning device 49 along the axes XYZ. Alternatively, the ultrasonic transducer 10 may be mounted in the desired position by the operator.

In accordance with a preferred embodiment of the present invention, the chamber 46 is used to obtain images of the body, which must be carried out lipolysis. The image of the body of the patient obtained from the camera is preferably displayed in real time on the display 48.

The operator can designate the contours of the zone containing the adipose tissue. In accordance with a preferred embodiment of the present invention, the designation of the zones is produced by labeling the operator of the patient's skin contour line 50, the image is transferred to the camera 46 is displayed on the display 48, and used by the computer 44 controls lipolysis for controlling the ultrasound radiation at different points within said area . The contour could also be calculated by the computer and displayed on the display 48, as indicated by reference 52. In an alternative embodiment, the operator may make a virtual marking of the skin, for example, using a digital converter (not shown), which can also create a path 52, the computer calculated and presented in display 48.

In addition to providing the circuit 52 with the device according to the present invention, also using markers 54 which are typically located outside the area containing the adipose tissue, although they may be located within the area encircled circuit 50. The markers 54 are optically distinguishable markers which can be clearly seen camera 46 which takes them and displays on the display 48. Markers 54 may be natural anatomic markers, such as some part of the body or alternatively artificial markers such as colored stickers. These markers are used to correct operation of the device during the deformation zone nominally designated contour line 50, due to movement and reorientation of the body. Preferably, converter 10 also includes a visual marker 56 which can also be captured by the camera 46 and displayed on display 48. Markers 54 and 56 are typically processed by a computer 44 and can be displayed on the display 48 as a corresponding computer representation 58 and the marker 60 on the display 48.

1 shows a converter 10 disposed on the body in an area containing the adipose tissue. Rectangles marked with numbers 62 and 64 show typical portions of a zone containing adipose tissue lipolysis before and after, respectively, in accordance with a preferred embodiment of the present invention. When comparing the rectangles 62 and 64 considerably, in accordance with a preferred embodiment of the present invention, within the zone comprising adipose tissue, adipose tissue, numbered 66, is split, while lean tissue such as connective tissue, designated by the number 68, is not cleaved .

Figure 2 shows a simplified block diagram of a power source 40 and the modulator (1) made according to the preferred embodiment showing the variation of ultrasonic pressure over time in accordance with a preferred embodiment of the present invention. As shown in Figure 2, the power supply unit 40 and the modulator comprises a signal generator 100 which generates a time-varying signal is modulated in such a way as to obtain a series of wave packets 102 with relatively high amplitude vibrations, separated in time by a series of wave packets 104 with respect to low amplitude oscillations. Each wave packet 102 with a relatively high amplitude corresponds to the period of void formation and preferably has decreasing amplitude over time.

Preferably, the ratio between the duration of time the packet 102 and 104 such as to create a duty cycle ratio of 1: 2 to 1: 250, more preferably from 1: 5 to 1:30, and most preferably from 1:10 to 1:20.

Preferably, the output of oscillator 100 has a frequency in the range of 50-1000 kHz, more preferably - in the range 100-500 kHz, and most preferably in the range of 150-300 kHz.

The output of generator 100 is fed to a suitable power amplifier 106, which supplies an output signal through the matching circuit 108 to the input of the ultrasonic transducer 10 (Figure 1), which converts the received electrical signal into a corresponding output ultrasonic radiation. As shown in Figure 2, ultrasonic waves output comprises a time varying signal which is modulated in accordance with the output of the generator 100 so as to obtain a series of relatively large amplitude oscillations, numbered 112 and 102 corresponding wave packets separated in time series fluctuations usually relatively small amplitude, numbered 114 and 104 corresponding wave packets.

Each series of 112 large-amplitude oscillations with respect to the period corresponding to the formation of voids and has an amplitude in the target area 12 (1) of the body, which exceeds the threshold 120 of the process voids and preferably has a decreasing amplitude over time. At least the initial pulse of each series of 112 oscillation amplitude is relatively large amplitude in the target area 12, which also exceeds the threshold 122 start the formation of voids.

Series 114 relatively small amplitude vibrations have an amplitude below both thresholds 120 and 122, respectively.

Preferably, the ratio between the length of time portions 112 to 114 is such as to create a duty cycle with a ratio of 1: 2 to 1: 250, more preferably from 1: 5 to 1:30, and most preferably from 1:10 to 1:20.

Preferably, the output of the ultrasonic signal of the ultrasonic transducer 10 has a frequency in the range of 50-1000 kHz, more preferably - in the range 100-500 kHz, and most preferably in the range of 150-300 kHz.

Preferably, each series of 112 oscillations of high amplitude comprises from 2 to 1000 sequential cycles at amplitude exceeding the threshold 120 of the process the formation of voids, more preferably - 25 to 500 consecutive cycles, the amplitude exceeding the threshold 120 of the process the formation of voids and most preferably - between 100 and 300 sequential cycles at amplitude exceeding the threshold 120 of the process the formation of voids.

3A and 3B shows a simplified appearance of the display to the operator interface during the normal course of the process and deviations from the normal course of the process, respectively. As shown in Figure 3A, in the normal course of the process display 48 normally displays the target region 12 (Figure 1) inside the calculated target zone 200 generally limited screen representation of the contour line 52 (Figure 1). Additionally, the display 48 displays one or more pre-programmed messages 202 about the progress and status messages 203.

As shown, a different target area 12 are displayed using different fills, so that each fill type reflects the current state of the art processes. For example, the target area without pouring designated with 204, has gone through the process of lipolysis. The shaded area of ​​the target 12, reference number 205, is the next stage in the passage of lipolysis. Partially shaded target area 206 generally represents the target area that has been insufficiently treated, in order to achieve complete digestion of adipose tissue, typically due to insufficient treatment duration.

Other types of target areas, e.g., not processed due to insufficient amount of adipose tissue in the art or otherwise, can be indicated by filling a suitable color or other means, and are shown in Figure 3A at numbers 208 and 210.

Typical posts 202 on the process can be as follows: "There is a creation of voids" and "Fat split in this area." Typical status messages 203 may contain information about the radiation power, operating frequency, the number of target areas within the 12 specific target areas and quantity of the remaining target areas 12 to be lipolysis.

The display 48 also comprises a graphical representation 212 cross section obtained by the ultrasound imaging created by the image forming unit 23 (Figure 1) of the ultrasonic transducer. Image 212 displays various tissues of the body in cross section and shows the relative arrangement of the target areas 12. In accordance with a preferred embodiment of the present invention, the image display 212 can also visually discernible image of the formation of voids within the target area 12.

3B shows that in the course of the process with abnormalities display 48 indicates the programmed error message 214.

Common error messages can be as follows: "Bad acoustic contact", "too hot." The message "too hot" generally refers to the temperature of the skin tissue, although it may alternatively or additionally relate to other tissue inside or outside the target area, or to a temperature transducer 10 (Figure 1).

Figure 4 is a simplified block diagram of ultrasonic lipolysis apparatus constructed in accordance with a preferred embodiment of the present invention. As shown above with reference to Figure 1, and as shown in Figure 4, the apparatus comprises an ultrasonic lipolysis lipolysis control computer 44, information of which is displayed on display 48. Computer 44 controls lipolysis receives input from the video camera 46 (Figure 1) and from temperature measuring unit 300 which obtains information about a predetermined temperature threshold value, and information on skin temperature sensor 34 (Figure 1) and the temperature sensor 36, the transducer (1). Temperature measurement unit 300 compares the output signals from the two sensors 34 and 36 with respective predetermined threshold values ​​and transmits data thresholds are exceeded at any of lipolysis control computer 44. Lipolysis control computer 44 also receives input information from sensor 302, tracking ultrasonic radiation. In certain embodiments of the invention, instead of said sensor 302 that observes the ultrasonic radiation 302 can be used for monitoring acoustic contact receiving information from block 304 measuring electrical characteristics of the converter (shown in the drawings). Measurement unit 304 monitors the electrical characteristics of the transducer output signal from the power supply module 40 and a modulator (1) to an ultrasonic therapeutic transducer 13.

The output of block 304 measure electrical characteristics of the converter is also provided to power meter 306, which provides an output signal to lipolysis control computer 44 and a feedback signal to the power supply unit 40 and the modulator (1).

Lipolysis control computer 44 also receives input information from sensor 308 that observes the formation of voids, identification module 310 and fabric layers 312, identification module digested fat tissue, each of which receives input from a module 314 of the ultrasonic reflection analysis. Ultrasound analysis module 314 receives input ultrasonic reflection information from ultrasound images simulating subsystem 316, that controls the image forming unit 23 (Figure 1) of the ultrasonic transducer. In some embodiments, instead of the sensor 308 that observes the formation of voids can be used voids detection module 308 (shown in the drawings).

Lipolysis control computer 44 transmits the output data to the module 40 and the power supply of the modulator to control the therapeutic ultrasonic transducer 13 and the ultrasonic image simulating subsystem 316 to control the ultrasound image forming unit 23, the inverter. Position control module 318 also receives the output from the computer 44 to lipolysis control device 49 controls the positioning of the axes XYZ (Figure 1), in order to correctly position transducer 10 containing the ultrasonic therapeutic transducer 13 and ultrasonic imager 23, the transducer assembly.

5A, 5B and 5C together a simplified flowchart illustrating operator steps in carrying out lipolysis procedure in accordance with a preferred embodiment of the present invention. As shown in Figure 5A, the operator initially conducts contour line 50 (Figure 1) on the body of the patient. Preferably, the operator also places on the patient stereotactic markers 54 (Figure 1) and a converter 10 comprising a marker 56 in the desired position within the circuit 50.

Chamber 46 (Figure 1) captures an image of the contour line 50 and markers 54 and 56. Preferably, the contour line 50 and markers 54 and 56 are displayed on the display 48 in real time. The output signal from the camera 46 and transferred to the memory associated with the computer 44 control lipolysis (1).

Computer tracking module configured to lipolysis control computer 44 uses the output of the camera 46 to calculate the computer representation of the contour line 52, which can be displayed for operator information on the display unit 48. The computer also calculates the coordinates of the tracking target area for lipolysis and adds the amount of the target areas to the total volume of tissue requiring lipolysis.

Preferably, the operator confirms the location of the markers 54 and 56 on the display 48, and a computer tracking module calculates the appropriate screen representation of the markers 58 and 60.

In accordance with a preferred embodiment of the present invention, the computer used in the tracking markers 54 and display representations of markers 58 to provide a continuous record of the contour line 50 on the screen representation of the contour line 52 and thereby control the target areas 12 with respect to the patient's body, despite the movement of the body of the patient during the procedure, e.g., associated with the breathing or any other movements, such as when the patient is away and returned to the site of the procedure.

Tracking computer module selects an initial target area for processing and position control module 318 (Figure 4) calculates the necessary change in the location of the transducer 10. The positioning device 49 along the axes XYZ converter 10 changes the position so as to position it over the selected target area.

As shown in Figure 5B, the subsequent change in location of the transducer 10, lipolysis control computer 44 confirms the current location of the transducer 10 with respect to the selected target area. Modeling image subsystem 316 (4) activates the ultrasound image forming unit 23, converter, causing the inclusion in the module 314 of the ultrasonic reflection analysis for analysis.

On the basis of the output signal from unit 314 is determined by analysis of the reflection of the ultrasonic thickness of different layers of the body tissue of the patient. Upon receipt of the information on the thickness of the layers of fabric, the operator can confirm the target area and activate the power supply unit 40 and the modulator (Figure 1).

As shown in Figure 5C, includes the following modules:

Block 304 measuring electrical characteristics of the converter supplies an output signal to the monitoring unit 302 of the acoustic contact, which determines whether the specified acoustic contact with the patient's body sufficient, preferably by analyzing the current and voltage at therapeutic transducer 13. Block 304 measuring electrical characteristics of the converter and provides an output signal wattmeter 306, which calculates the average electrical power received by the therapeutic transducer 13. If the average electrical power received by the therapeutic transducer 13 exceeds a preset threshold, the work module 40 and modulator supply can be automatically stopped.

Skin temperature sensor 34 measures the current temperature of the skin in the area of ​​the converter 10 and transmits this information to the temperature measuring unit 300 which compares the skin temperature to a threshold. Similarly, transducer temperature sensor 36 measures the current temperature of the inverter 10 and transmits this information to the temperature measuring unit 300 which compares the temperature in the converter with a threshold value. Output data from the temperature measuring unit 300 is transmitted to the computer 44 controls lipolysis.

Modeling image subsystem 316 controls the ultrasound image forming unit 23 and the transmitter receives the output image, which is analyzed with the analysis unit 314 of the ultrasonic reflection. The result of analysis is used to detect voids and void detection result is transmitted lipolysis control computer 44.

In case of any of the following four conditions is the power supply unit 40 and automatically stops the modulator therapeutic transducer 13. If the execution of any one of the following four conditions is not detected, the automatic operation of the module 40 and the power source modulator 40 continues:

1. Acoustic contact is insufficient.

2. Skin temperature exceeds threshold

3. The temperature in the converter 13 exceeds the threshold value.

4. There was no voids.

As shown in Figure 5B, during the automatic operation of the power supply unit 40 and the modulator 46 is preferably a video camera records an image of the target zone and notes whether the transducer 10 remained stationary during the entire duration of the selected processing target area 12. If the transmitter was fixed and if none one of the above four conditions has not been fulfilled, the control computer 44 lipolysis confirms that the selected target area is treated. Then, the computer unit of the computer monitor 44 control lipolysis offers to handle the next target area 12.

If, however, revealed that the transducer 10 is not remained motionless for a long enough time, the selected target area marked lipolysis control computer 44 as an area not sufficiently treated.

It should be noted that the use of several transducers can be processed by a plurality of target areas at different time patterns, for example, using successive or partially overlapping time intervals.

It should also be noted that several target areas may be partially or completely overlapping in space.

The embodiment of the claimed method carried out in relation to female pigs is described below. The method comprises several stages of preparation and analysis steps.

Preparation of adipose tissue

A female pig, which weighed about 100 kg, fat and tissue covering the muscle to split the fascia. The dissection was performed immediately after killing the animal. Depth of incision of approximately 2 cm. Later, the skin and fat are kept at 4 ° C for no longer than 12 hours. Immediately after the application of ultrasound was separated from the animal cylindrical segment (1 cm diameter and 2 cm in height) having skin, fat and muscle tissue. The resulting sample was kept in buffered formaldehyde solution for 48 hours (the company Bio-Lab, Israel).

Histopathology

To prepare the sample used standard histological techniques. Company Path-Lab Ltd (Israel) to implement the conclusion of the tissue, as well as its processing and sectioning with hematoxylin and eosin. For the study of the effects of ultrasound along the axis of treatment, each sample was cut lengthwise.

Microscopic analysis

Microscopic analysis was performed using a light microscope (Leica) with an increase of 50, 100 and 400. To record images to a microscope hooked up a video camera, controlled by a computer program to capture images (CMS-1, AMS Ltd., Israel). During each scan, which is carried out for each zoom ratio, tested five zones. The extent of tissue damage is determined by the appearance of "shadows" cell membranes rupture and the formation of cysts, different in size and volume. The increase of 400 was used to observe fine details of possible damage within the study area. The research results were analyzed by pathologists and scientists independently.

For characterization, evaluation and analysis of the data using two scales.

(1) Scale of lipolysis:

Damage to the fat cells was investigated by increasing 50 (to maximize the size of the zone) and classified into 4 degrees:

0 degree - no damage; intact, untouched tissue; looks like a conventional manner (up to 10% of the damage may be of a technical nature and therefore classified as grade 0).

Grade 1 - minimal damage; "Shadow" cells microcysts size of 2-3 cells, 10-25% damage.

Grade 2 - significant damage; "Shadow" cells, large cell size of 5 microcysts 26-50%.

Grade 3 - very large damage; "Shadow" cells microcysts large and larger cysts form 51-100%, or total destruction of tissue, damaged cells with damaged shell.

(2) The scale of non-specific damage

0 degree - no damage; intact, untouched tissue.

Grade 1 - damage there; description of the damage will be added.

These scales were chosen because the desired effect of ultrasound absolutely should not harm other tissues other than fat. Possible damage to connective tissue, nerve endings and blood vessels (arteries and veins, and microvessels) within the adipose tissue, or surrounding tissues (skin and muscle) tested at a magnification of 50, 100 and 400. Large zoom factors are used to distinguish minor changes (Illustrations not shown). During the research the following results and the corresponding conclusions.

Optimization of pulse parameters

To determine the therapeutic index is necessary to determine the relation between the impulse responses. We studied four characteristics: the length of the pulse repetition period of the pulses, the total time of sonication and peak electric power of ultrasound. To determine the correct ratio between these four parameters to ensure excellent digestion of adipose tissue, it was carried out four tests. Each test was changed one parameter, the other parameters at the same time remains constant. During the first two trials investigated the pulse repetition rate and pulse length. Peak electric power was kept constant at 150 W (just at the level of voids), the total sonication time was kept constant at 5 sec.

In the first experiment, the pulse length was kept constant and equal to 1.6 milliseconds.

The pulse repetition period is increased from 5 ms to 100 ms (5 ms, 10 ms or more in 10 ms, n = 11).

In the second experiment, the pulse repetition period is maintained constant and equal to 20 ms. Pulse length was increased from 0.04 ms to 4 ms (0.04, 0.2, 0.4 and further 0.4 ms increments, n = 12).

The results of the efficiency of fat digestion are shown in Table 1.

Table 1Eksp.Dlina imp. (ms) The repetition of pulses. (ms) Ultrasound treatment time. (c) The Queen of RE. weekend. powerful. (W) Scale cleaved. zhiraShkala povrezhd.11,65515000 1.610515030 1.620515030 1.630515030 1.640515030 1.650515030 1.660515030 1.670515020 1.680515010 1.690515000 1,610051500020,0420515000 0.220515000 0.420515000 0.820515010 1.220515020 1.620515030 2.020515030 2.420515030 2.820515030 3.220515030 3.620515030 4.020515030

Presented in Table 1 show that the excess of the pulse repetition period of 60 ms value reduces the efficiency of splitting. Up to a certain level of saturation corresponding to the pulse length of 1.6 ms, there is a direct relationship between the pulse length and the efficiency of cleavage is not observed any damage to surrounding tissue.

During the subsequent trial investigated the total time of sonication and summing the peak electrical power. The length of the pulse and the pulse repetition frequency remained constant. The length of the pulses remained unchanged and equal to 1.6 ms, while the pulse repetition period is maintained constant and equal to 20 ms.

Power changes to increase 4 times 150 watts of peak electrical power up to 300 watts increments of 50 watts. Total time of sonication, the increment of 6 times at control points 0.1, 0.5, 1, 2, 5 and 10 (a total of 24 experiments).

Results cleavage efficiency are shown in Table 2.

Table 2Eksp.Dlina imp. (ms) The repetition of pulses. (ms) Ultrasound treatment time. (c) The Queen of RE. weekend. powerful. (W) Scale cleaved. zhiraShkala povrezhd.31,6200,115000 1,6200,120000 1,6200,125010 1,6200,130020 1,6200,135020 1,6200,515000 1,6200,520010 1,6200,525020 1,6200,530030 1, 6200.535030 1.620115010 1.620120030 1.620125030 1.620130030 1.620135030 1.620215010 1.620220030 1.620225030 1.620230030 1.620235030 1.620515020 1.620520030 1.620525030 1.620530030 1.620535030 1, 6201015020 1.6201020030 1.6201025030 1.6201030030 1.6201035030

Presented in Table 2, the results show that the ultrasonic radiation destroys only the adipose tissue, leaving intact the surrounding tissue and organs located in the area to be treated. In the case of ultrasonic radiation low power (150W) nonintensive cleavage occurs. At 150 W 10-fold increase in processing time only led to a doubling of the level of destruction that does not exceed 50%. Ultrasound radiation power of 200 watts or more results in the most effective breakdown of fat, even with such a short processing time of 0.1 s. Ultrasound radiation of 350 W, if the processing time is 0.5 seconds, resulting in the most effective breakdown of fat, leaving untouched the surrounding tissue.

The following describes the application that contains a software module object code of computer monitor and includes the following steps:

1. Ensure that the computer such as PC, for example, Pentium III 800MHz based Intel, the operating system Microsoft Windows 2000 with hard drive capacity of at least 10 GB, one free PCI slot and a 17 '' monitor.

2. Install and configure the Matrox Orion Frame Grabber Hardware:

a) Remove / disable board VGA, available on the computer PC.

b) Set up fee Matrox Orion Frame Grabber, available from Matrox (1055 boul. St-Regis, Dorval, Quebec Canada H9P 2T4) available PCI slot in the computer PC.

c) running Microsoft Windows 2000, when you start your computer built-in Plug-and-Play detects a new multimedia video device and ask to install the driver. In this step, press "Cancel".

d) Install the camera JAI CV-S3200 DSP Surveillance Color CCD, available from JAI America Inc., Avenida de la Carlota, Suite 450, Laguna Hills, CA 92653 United States, and connect it to Matrox Orion Framer Grabber.

e) Put the computer monitor impedance switch to position 75 Ohm for red, green and blue.

f) Fit the clock inputs of the monitor to high impedance mode, and external synchronization.

g) Connect the monitor output 15-pin VGA connector of the Matrox Orion (DB-15).

3. Install the software Matrox MIL-Lite (version 6.1.):

a) Launch the setup.exe program Matrox MIL-Lite and follow reports the default settings.

b) Start Matrix Expansion Pack (Version 1.0).

c) Select «PAL-YC mode of grabbing» when prompted.

d) Set the format of the series connection of the RS-232 between the computer and the camera JAI by registering and installing the program «JAI camera ActiveX object».

4. Install Tracking Software Track Software:

a) Create the following directories, respectively

(1). <Track root> - the root directory for the project Track

(2). <Track root> \ Src - contains source files

(3). <Track root> \ Debug - contains an executable project Track

(4). <Track root> \ Images - contains a BMP file to debug the internal process of determining the area

(5). <Track root> \ Log - contains the log files and images in BMP environment

(6). <Track root> \ Timing - contains files with temporary data for debugging

b) Establish a file TRACKOBJ.HEX based Applications and place it in a temporary directory.

c) Convert from hexadecimal contents of the file in decimal TRACKOBJ.HEX, using the program HEX IT vers.1.8 or higher supplied John Augustine, 3129 Earl St., Laureldale Pa 19605, create a file TRACKOBJ.ZIP.

d) Unzip the file TRACKOBJ.ZIP, using WINZIP vers.6.2. or higher, putting the extracted files in the temporary directory. Also we unpacked the following files:

1). CAMERADLG.OBJ

2). DISPLAYFUNCS.OBJ

3). IMAGEPROC.OBJ

4). INTERIORREGION.OBJ

5). MARKERS.OBJ

6). NODES.OBJ

7). PARAMETERSDLG.OBJ

8). STDAFX.OBJ

9). TRACK.OBJ

10). TRACK.RES

eleven). TRACKDLG.OBJ

12). TRANSDUCER.OBJ

13). UTILS.OBJ

14). VIDEOMATROX.OBJ

e) Compile the object code stored in the temporary folder you created in step 4d, using the compiler Microsoft Visual C ++ version 6.0. This will create the final application TRACK.EXE.

f) In order to run the software Track, you must run the file TRACK.EXE and follow the online prompts to work with the program.

It should be noted that software components of the present invention may optionally be sewn into the ROM (read only memory). The software components may, generally built in hardware, if desired, using conventional techniques.

It should also be noted that the particular embodiment is presented in the Appendix is ​​intended only to provide only a detailed description of the present invention and is not limiting description.

It should also be noted that the present invention is not limited by what has been particularly shown and described above. More specifically, the present invention includes various embodiments and combinations of various combinations of the features described above, as well as their variations and modifications that will be apparent to those skilled apparent claim When reading the specification and which are not known in the prior art.

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